CTRI/2023/08/056505
Not yet recruiting
Phase 2
Efficacy and Safety of Intranasal Application of Human Milk for Neuroprotection in Neonates with Hypoxic Ischemic Encephalopathy: A Pilot Randomized Controlled Trial - NI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: P969- Condition originating in the perinatal period, unspecified
- Sponsor
- Banaras Hindu University
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Term or post term neonates will be recruited to the trial if they meet both of the following two criteria of eligibility: first, a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home); and second, evidence of encephalopathy based on clinical examination using modified Sarnat staging
Exclusion Criteria
- •1\. Chromosomal anomalies
- •2\. Major congenital malformation
- •3\. Microcephaly
- •4\. Dysmorphic features
- •5\. Suspected intrauterine infection
- •6\.Failure to obtain consent
Outcomes
Primary Outcomes
Not specified
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